periodic report - king's college london · 2017-06-21 · the attached periodic report...

EUROPEAN COMMISSIONRESEARCH AND INNOVATION DG Periodic Report

Project No: 261411

Project Acronym: STOP

Project Full Name: Suicidality: Treatment Occurring in Paediatrics

Periodic Report

Period covered: from 01/11/2010 to 30/04/2012 Date of preparation: 20/07/2012

Period number: 1st Date of submission (SESAM):

Start date of project: 01/11/2010 Date of submission (SESAM):

Project coordinator name:Dr. Paramala Santosh

Project coordinator organisation name:UNIVERSITY COLLEGE LONDON

Version: 1

Periodic Report

PROJECT PERIODIC REPORTGrant Agreement number: 261411

Project acronym: STOP

Project title: Suicidality: Treatment Occurring in Paediatrics

Funding Scheme: CP

Date of latest version of Annex I against whichthe assessment will be made:

13/12/2010

Period number: 1st

Period covered - start date: 01/11/2010

Period covered - end date: 30/04/2012

Name of the scientific representative of theproject's coordinator and organisation:

Dr. Paramala Santosh UNIVERSITY COLLEGELONDON

Tel: +447866362544

Fax: +442078138411

E-mail: [email protected]

Project website address: www.stop-study.com

Project No.: 261411Period number: 1stRef: intermediateReport1130472

Page - 2 of 24

Declaration by the scientific representative of the project coordinator (1)I, Dr. Paramala Santosh UNIVERSITY COLLEGE LONDON , as scientific representative of the coordinator ofthe project STOP and in line with the obligations as stated in Article II.2.3 of the Grant Agreement declare that:

The project has achieved most of its objectives and technical goals for the period with relatively minordeviations.

The attached periodic report represents an accurate description of the work carried out in this project for thisreporting period.

The public website is up to date.

To my best knowledge, the financial statements which are being submitted as part of this report are in line withthe actual work carried out and are consistent with the report on the resources used for the project (section 6)and if applicable with the certificate on financial statement.

All beneficiaries, in particular non-profit public bodies, secondary and higher education establishments,research organisations and SMEs, have declared to have verified their legal status. Any changes have beenreported under section 5 (Project Management) in accordance with Article II.3.f of the Grant Agreement.

Name Dr. Paramala Santosh UNIVERSITY COLLEGELONDON

Date

This declaration was visaed electronically byParamala SANTOSH(ECAS user name nsantopl) on


Page - 3 of 24

1. Publishable summarySummary description of project context and objectives

The emergence of suicidality in patients receiving drug treatment is of concern because of the overallburden and the possible link with completed suicide. The lack of uniform requirements for defining,detecting and recording suicidality and the presence of disease related confounders create majorproblems. It is possible that Medication-Related Suicidality (MRS) differs fromPsychopathology-Related Suicidality (PRS) in terms of phenomenology, clinical expression and timecourse, and may vary between children and adults. Unlike PRS, the time-course of MRS may beassociated with possible differences in drug pharmacokinetics; abrupt onset; absence of suicidalityprior to start of medication; and emergence of suicidality related co-morbidities after treatment.STOP focuses on developing a web-based comprehensive methodology for the assessment andmonitoring of suicidality and its mediators in children and adolescents using the HealthTrackerTM (apaediatric web-based health outcome monitoring system), with the aim of developing a web-basedSTOP Suicidality Assessment and Monitoring Suite consisting of the STOP Suicidality AssessmentScale, the STOP Risk and Protective Factors Scale (which includes bio-psycho-social factors andsuicidality-related psychiatric and physical illness factors) and the STOP Medication Related Scale.The information obtained will be used to computer-generate classification of suicidality using theClassification of Suicide-Related Thoughts and Behaviour (Silverman et al, 2007) and the ColumbiaClassification Algorithm of Suicidal Assessment (C-CASA) (Posner et al, 2007). An extendedMedication Characteristics Module will be developed to allow documentation of pharmacologicalcharacteristics of medication, and specific aspects necessary as per the standard operating procedure(SOP) developed as part of the biological factors related to suicidality (developed in WP3). Themethodology will then be tested in 3 paediatric observational trials to examine whether theweb-based system (compared to the C-CASA) can be used in a variety of paediatric groups.The Antipsychotic-prescribed Cohort consists of a sample of 400 children and adolescents onantipsychotics (Risperidone) and 250 normal controls. This sample will allow a detection of anincrease in suicidality of from 3 per 100 to 8 per 100 with about 80% power. Subjects and theirparents will complete the STOP newly developed web-based measures over a 52-week period, tocharacterize the new measure against the C-CASA. This will demonstrate the capability of theweb-based STOP measures to reliably measure suicidality in a paediatric group with psychiatricconditions that generally do not have suicidality as a core symptom (for example, conduct disorder,autism, psychosis) but have required the initiation of Risperidone, an antipsychotic.The Depression Cohort consists of a sample of 240 depressed children and adolescents patients (N=120 Fluoxetine-treated, N= 120 non-medication treated), which will allow us to ensure that indepression (whether treated with medication or psychological interventions). Subjects and theirparents will complete the STOP newly developed web-based measures over a 52-week period, tocharacterize the new measure against the C-CASA. This will demonstrate that the STOP measurescan reliably be used in those with a psychiatric illness such as depression that inherently hassuicidality as a symptom.The Bronchial Asthma Cohort consists of a sample of 240 children and adolescents (N= 120Montelukast-treated, N= 120 non-medication treated). Subjects and their parents will complete theSTOP newly developed web-based measures over a 52-week period, to characterize the new measureagainst the C-CASA. This will demonstrate that the web-based STOP measures can be used reliablyin a paediatric group with a physical illness (bronchial asthma) for which medication prescribed havebeen hypothesised to be linked to suicidality (Montelukast).In summary, the three cohort studies have been designed to demonstrate that the web-based STOPSuicidality Assessment and Monitoring Suite can be used in a variety of paediatric conditions andthat it is at least as good as the current gold standard, the C-CASA. The final, validated web-basedSTOP Suicidality Assessment and Monitoring Suite will be developed in a manner that it can beadapted in the future, to be used on hand-held systems such as mobile phones and hand-heldcomputers such as IPads etc if we receive additional funding. The web-based STOP SuicidalityAssessment and Monitoring Suite with all the measures will be able to be used forpharmacovigilance, epidemiological, observational, and registration trials.

Description of work performed and main results

After reviewing the literature regarding risk and protective factors for suicidality in children and


Page - 4 of 24

adolescents, we developed different versions of a comprehensive assessment of suicidality and itsbio-psycho-social mediators (including psychopathology, biological, psychological and social riskand protective factors, and medication characteristics) in children and adolescents. This has beenachieved with the scales having been developed using standardized methodology, translated intoSpanish, French, German, Dutch and Italian, and converted into a modular, web-based STOPSuicidality Assessment and Monitoring Suite. The STOP Suite consists of the STOP SuicidalityAssessment Scale, the STOP Risk and Protective Factors Scale (which includes bio-psycho-socialfactors and suicidality-related psychiatric and physical illness factors) and the STOP MedicationRelated Scale - each of which has versions for use by children 8-11 years old, adolescents, parents,and for clinicians. This is currently being modified for children aged 5 to 7 years. To ensure thatquestions are appropriate for each target population, focus groups were carried out. In addition,suggestions from all members of STOP project and the Scientific Advisory Board were taken intoaccount. The information obtained will computer-generate classification of suicidality using theClassification of Suicide-Related Thoughts and Behaviour (Silverman et al, 2007) and the ColumbiaClassification Algorithm of Suicidal Assessment (C-CASA) (Posner et al, 2007).As part of STOP we designed a methodology for detecting signals of suicide-related adverse events(SRAEs) related to medication, using data from the Vigibase database (maintained by the WHOUppsala Monitoring Centre in Sweden) and conducted a systematic review on medications identifiedfrom this as having signals of SRAEs in children and adolescents. Specifically, fluoxetine,montelukast and risperidone were investigated in detail to identify whether there were any otheradverse events were being consistently reported with SRAEs. This has been compiled as a report andresults are being submitted for publication. We have also developed specific recommendations onhow to report medication-related suicidality events in published literature.We also specifically studied SRAEs in those who were exposed to montelukast from The HealthImprovement Network (THIN) data set which holds data from 5% of the UK ‘population entered bygeneral practitioners and records exposure to drugs (including montelukast) and codes demographics,details from general practitioner’s visits, diagnoses (including mental health morbidity) fromspecialist referrals and hospital admissions, and the results of laboratory tests. Data on around 2.9million active patients are systematically recorded and sent anonymously to THIN. The latest datasetcontains information on over 7.7 million patients from 429 general practices in the UK anddescriptive analysis of the data is complete showing that we cannot be definite about the linkbetween montelukast and suicidality. We are awaiting advice from an expert statistician for statisticalanalysis for the self-controlled case series method.As had been originally proposed, we have explored what is the best method and sample sourcenecessary to obtain good enough yield and quality for biological risk factor analyses necessary inchildren and adolescents. The yield and quality from 2.5 ml of saliva processed using Oragene.Dx®kit was shown to be good and “fit for purpose,” specifically, for a range of genomic applications,including single nucleotide polymorphism (SNP) analysis, variable number tandem repeat (VNTR)genotyping, long-range polymerase chain reaction (long-PCR), methylation assays, and genotypingusing microarray technology. For children <12y, we have developed a modified extraction protocoland an Standard Operating Procedures (SOP) for DNA sampling in children and adolescents hasbeen generated. Standard Operating Procedures (SOPs) are also being developed for use in childrenfor sampling of urine for metabolomics and for serial urine testing for urine drug screen (UDS).Unfortunately, saliva samples are not good enough (compared with capillary blood samples) tomeasure levels of medication and their metabolites (risperidone, fluoxetine, montelukast). Theseresults are currently being written up for publication.

Expected final results and potential impacts

The STOP Suicidality Assessment and Monitoring Suite that has been developed consists of theSTOP Suicidality Assessment Scale, the STOP Risk and Protective Factors Scale (which includesbio-psycho-social factors and suicidality-related psychiatric and physical illness factors) and theSTOP Medication Related Scale – each of which has versions for use by children 8-11 years old,adolescents, parents, and for clinicians and is available in English, Spanish, French, German, Dutchand Italian. A version to be used by children aged 5 to 7 years is also being developed.The information obtained will computer-generate classification of suicidality using the Classificationof Suicide-Related Thoughts and Behaviour (Silverman et al, 2007) and the Columbia ClassificationAlgorithm of Suicidal Assessment (C-CASA) (Posner et al, 2007). This validated web-based suitewill allow it to be used in pharmacovigilance whenever a new drug is introduced in children andadolescents (or for that matter in adults) so that we can prospectively monitor medication related


Page - 5 of 24

suicidality. This will have immense value because risk of suicidality can be identified early andintervention provided. If certain medication side-effects are highly correlated to suicidality, asidentified in the three cohort studiies, we may be able to identify side-effects that should alertclinicians to explore further about suicidality in routine clinical practice.The STOP Suicidality Assessment and Monitoring Suite can also be used to monitor suicidality inroutine clinical care, especially when one wants to cost-effectively reduce clinician time being spentexploring this issue in subjects not suspected as being suicidal. This can also be used in differenthigh-risk groups thus hopefully reducing suicidality through early detection and intervention. TheSTOP Suicidality Assessment and Monitoring Suite will have implications for intellectual propertyexploitation and this will be done using the principles outlined in the application with HealthTrackerLtd. The final web-based system can be modified for hand-held computers (such as IPads) andmobile phones if we are able to secure further funding. This would make it even more user friendlyand will enhance its use.Publications arising from our analyses for detecting signals of suicide-related adverse events(SRAEs) related to medication, using data from the Vigibase database (maintained by the WHOUppsala Monitoring Centre in Sweden) in children and adolescents as well exploring montelukast inThe Health Improvement Network (THIN) data set containing information on over 7.7 millionpatients from 429 general practices in the UK will increase understanding in this field.The clear deficits that exist in the current serious side-effect reporting systems especially the lack ofa standardized methodology for doing so have been highlighted and we have developed specificrecommendations on how to report medication-related suicidality events in published literature. Thiswill improve the usefulness of this in subsequent reviews of whether a drug may causally be involvedin suicidality or not.As have also shown that biological risk factor analyses of suicidality in children and adolescents canbe achieved from 2.5 ml of saliva processed using Oragene.Dx® kit was shown to be good and “fitfor purpose,” specifically, for a range of genomic applications, including single nucleotidepolymorphism (SNP) analysis, variable number tandem repeat (VNTR) genotyping, long-rangepolymerase chain reaction (long-PCR), methylation assays, and genotyping using microarraytechnology. For children <12y, we have developed a modified extraction protocol and an StandardOperating Procedures (SOP) for DNA sampling in children and adolescents has been generated.Standard Operating Procedures (SOPs) are also being developed for use in children for sampling ofurine for metabolomics and for serial urine testing for urine drug screen (UDS). These results arecurrently being written up for publication and will assist in improving the collection of biologicaldata in studies regarding suicidality, thus increasing the likelihood of being able to understandcausality in different types of suicidality. This may help us identify high-risk groups and provideprophylactic interventions in multiple settings. In summary, the output from this project haswide-reaching implications as the various outputs from this project will allow the improvement offuture studies.

Project public website address: www.stop-study.com

2. Core of the reportProject objectives, Work progress and achievements, and project management during theperiod

The Project Summary Pdf document contains the core of the report.


Page - 6 of 24

3. Deliverables and milestones tables

Deliverables (excluding the periodic and final reports)

Del.no.

Deliverable name VersionWP no. Lead beneficiary Nature Disseminationlevel

Delivery date fromAnnex I (proj

month)

Actual / Forecastdelivery date

Status Comments

1 Periodic reports on months 01-18

1.0 1 UNIVERSITYCOLLEGELONDON

Report RE 18 01/04/2012 Submitted

2 Periodic reports on months 19-36


Report RE 36 01/10/2013 Not submitted

3 Final reports on months 37-42


Report RE 42 01/04/2014 Not submitted

1 Report of drugs associated with suicidality

1.0 2 THE SCHOOLOF PHARMACY,

UNIVERSITYOF LONDON

Report PU 18 01/04/2012 Submitted

2 Final report on meta-analysis and frequencies of s

uicidality events

1.0 2 THE SCHOOLOF PHARMACY,

UNIVERSITYOF LONDON


1 Report on SOPs (i.e.DNA sampling,

metabolomics, s ubst.abuse)

1.0 3 KING'SCOLLEGELONDON

Report CO 18 01/04/2012 Submitted

2 Report on pilot genotyping and methylation analyse

s.

1.0 3 KING'SCOLLEGELONDON


1 Report on methodologyfor assessment ofpsychosoci al risk

0.0 4 CONSORCIOCIBER PARA EL

AREATEMATICA DE

SALUDMENTAL

Report CO 18 31/12/2012 Not submitted Pilot trial have notsterted yet

2 Report on reliability andacceptability of psychos

ocial risk assessment too l


AREA

Report PU 42 01/04/2014 Not submitted


Page - 7 of 24

TEMATICA DESALUD

MENTAL

3 Finalised assessment toolfor use in future clinic al

trials


AREATEMATICA DE

SALUDMENTAL

Other PU 42 01/04/2014 Not submitted

1 Report on sensitivity, specificity and positive predictive value of scales

0.0 5 FUNDACIOPRIVADA

CLINIC PER ALA RECERCABIOMEDICA


2 First publication submitted to international journ

al

0.0 5 FUNDACIOPRIVADA

CLINIC PER ALA RECERCABIOMEDICA


1 Report on Functionality and Requirements ofHealth Tracker TM


Report CO 18 30/09/2012 Not submitted Will be completed onceHealthTracker Ltd isregistered as an SME.

However,HealthTracker Ltd hasalready been providingthe technology neededfor the uploading of theSTOP instruments andare working prior to the

transfer of funds tothem.

2 Health Tracker TM readyf or marketing


Other PU 42 01/04/2014 Not submitted

1 Report on study design, protocol and start

0.0 7 STICHTINGKATHOLIEKEUNIVERSITEIT

Report PU 18 30/09/2012 Not submitted Awaitingmedical-ethical

approval of protocol.Report will follow.

2 Publication(s) submittedto international journal

0.0 7 STICHTINGKATHOLIEKEUNIVERSITEIT


1 Report on study design, p 1.0 8 ZENTRALINSTITUT Report PU 18 01/04/2012 Submitted


Page - 8 of 24

rotocol and start FUERSEELISCHE

GESUNDHEIT


0.0 8 ZENTRALINSTITUTFUER

SEELISCHEGESUNDHEIT


1 Report on study design, protocol and start






1 Report on assessmentproc edures and quality

assure ment

0.0 10 UNIVERSITAETULM


1 Detailed reports to IRBs 0.0 11 UNIVERSITADEGLI STUDIDI CAGLIARI

Report CO 36 01/10/2013 Not submitted

2 Final detailed study reports for IRBs

0.0 11 UNIVERSITADEGLI STUDIDI CAGLIARI

Report CO 42 01/04/2014 Not submitted

3 Final report to submit fo rpublication on Qualitat

ive interview study (experiences as clinical resea

0.0 11 UNIVERSITADEGLI STUDIDI CAGLIARI


1 Summary of conferencesan d papers presented on

the website

0.0 12 ASSISTANCEPUBLIQUE -

HOPITAUX DEPARIS


Milestones

Milestoneno.

Milestone name Work package no Lead beneficiary Delivery date fromAnnex I

Achieved Yes/No Actual / Forecastachievement date

Comments

1 Project GoverningBoard Start-up Meeting

1 15 30/11/2010 Yes 11/11/2010

2 Project CoordinationCommittee Meeting

1 15 30/11/2010 Yes 11/11/2010


Page - 9 of 24


1 15 30/04/2011 Yes 21/05/2011

4 Project GoverningBoard Meeting

1 15 31/10/2011 Yes 06/12/2011


1 15 31/10/2011 Yes 06/12/2011


1 15 30/04/2012 Yes 09/06/2012


1 15 31/10/2012 No 31/10/2012


1 15 31/10/2012 No 31/10/2012


1 15 30/04/2013 No 30/04/2013

10 Review of possibilitiesfor exploitation andcontinued funding

1 15 30/04/2013 No 30/04/2013


1 15 31/10/2013 No 31/10/2013


1 15 31/10/2013 No 31/10/2013


1 15 30/04/2014 No 30/04/2014


1 15 30/04/2014 No 30/04/2014

15 Protocol ofsignal-generation

methodology

2 7 31/12/2010 Yes 07/01/2011 Submitted to SoPResearch EthicsCommittee on

07/01/2011; approved01/03/2011

16 Dataset available foranalysis

2 7 28/02/2011 Yes 06/12/2010

17 Protocol of systematicliterature review /

meta-analysis

2 7 30/04/2011 Yes 04/07/2011

18 Meeting to discuss SOPfor DNA sampling in

3 13 31/12/2010 Yes 31/03/2012


Page - 10 of 24

children and adolescents

19 Genotyping of candidatemarkers of relevance for

suicidality

3 13 31/01/2011 Yes 31/03/2012

20 Piloting the DNAsampling SOP

3 13 28/02/2011 No 27/10/2012 Delays due to ethicscommittee and the PERS

study

21 SOP for an appropriatemethod of DNAsampling agreed

3 13 31/03/2011 Yes 31/03/2012

22 Pilot analysis ofmediations being

studied in WPs 7-9

3 13 30/04/2011 No 30/11/2012 See core WP3 report.

23 Meeting to discuss SOPfor TDM for the clinical

studies

3 13 30/04/2011 Yes 06/12/2011

24 SOP for samplingmethod for

concentrations of themedications

3 13 31/07/2011 No 30/11/2012 See core WP3 report

25 SOP for an appropriatemethod of sampling for

UDS.

3 13 31/07/2011 Yes 20/05/2011

26 Methods ready for startof clinical studies

3 13 31/10/2011 Yes 30/04/2012 SOPs necessary forclinical studies to bedone; TDM SOP in

progress.

27 Literature review:Psychosocial risk factors

assoc. with suicidality

4 9 31/01/2011 Yes 30/05/2011

28 Measurements defined(adverse life events,temperament, etc.)

4 9 31/03/2011 Yes 30/05/2011

29 Psychosocial riskassessment tool

developed

4 9 31/05/2011 Yes 30/06/2011

30 Translations inpsychosocial riskassessment tool

4 9 30/06/2011 No 31/08/2012


Page - 11 of 24

completed

31 Methodology (studyprotocol) for assessment

of psychosocial risk

4 9 31/10/2011 No 31/08/2012

32 Data on reliability andacceptability of

psychosocial riskavailable

4 9 31/12/2013 No 31/12/2013

33 A first draft of the scaleof suicidality in its

different forms

5 10 28/02/2011 Yes 28/02/2011

34 Dataset available forstudy of reliability,factor structure and

validity

5 10 31/03/2011 No 30/07/2012 It will be done throughthe Health Tracker. It is

almost ready.

35 Results regardinginternal reliability and

factor structure

5 10 30/04/2011 No 01/08/2012 It will be done in alllanguages

36 Translated rating scalesin the different

languages

5 10 30/06/2011 Yes 30/06/2012

37 Data on sensitivity,specificity and positive

predictive value ofscales

5 10 31/01/2014 No 31/01/2014

38 Developed MedicationRecording Function

6 13 30/04/2011 No 01/10/2012 Basic MedicationRecording Function

Developed in October2011, being enhancedwith information nowobtained from SOPs

developed in WP3. Thiswill be complete by

01/10/2012

39 Suicidality Assessmentand Monitoring Module

in English

6 13 31/05/2011 Yes 30/07/2011

40 Suicidality Moderatorsand Mediators Modules

in English

6 13 31/05/2011 Yes 30/07/2011


Page - 12 of 24

41 Suicidality Assessmentand Monitoring Module

(translated + voice)

6 13 30/06/2011 No 01/10/2012 Translated into alllanguages but voice filesto be made and uploaded

42 Suicidality Moderatorsand Mediators Modules

(translated + voice)

6 13 30/06/2011 No 01/10/2012 Translated into alllanguages but voice filesto be made and uploaded

43 Focus group testing ofbeta version of

HealthTrackerTM

6 13 31/08/2011 No 15/07/2012 The beta version hasbeen tested by a

User-interface Specialistand by experts in

HealthTracker Ltd. Thesystem is to be tested and

used by subjects in thevalidation study starting

on 15/07/2012

44 Achieving GCPCompliance for theHealthTrackerTM

6 13 31/10/2011 No 01/10/2012 This will be achievedafter all measures

necessary for the threecohort studies are

uploaded intoHealthTrackerTM

45 Training/installation ofHealthTrackerTM in

different centres

6 13 30/04/2012 No 31/10/2012 This will be achievedafter all measures

necessary for the threecohort studies are

uploaded intoHealthTrackerTM

46 Provision ofmaintenance support for

HealthTrackerTM

6 13 31/05/2012 No 31/05/2012

47 Achieve reliability ofSuicidality Modules in

clinical studies

6 13 31/01/2014 No 31/01/2014

48 Developing Surveillanceand Pharmacovigilance

Modules

6 13 28/02/2014 No 28/02/2014

49 Commitments declared,contracts signed

7 2 30/11/2011 Yes 30/11/2011

50 Documents finalized,ready for submission

7 2 31/12/2011 Yes 31/12/2011

51 Approved protocol 7 2 31/01/2012 Yes 31/01/2012


Page - 13 of 24

52 Approvals (includingInstitutional Review

Boards) received

7 2 30/04/2012 No 30/08/2012 Awaiting approval forSTOP WP7 protocol atpresent from medical

ethical approval boards.

53 Kick off and trainingMeetings performed

7 2 30/04/2012 Yes 31/03/2012

54 CRF done, ready for use 7 2 30/04/2012 No 30/08/2012 CRFs are now linked tothose in PERS WP2 andWP3. Next to final draft

CRFs available.

55 Start recruitment (firstpatient in)

7 2 31/05/2012 No 31/05/2012

56 Recruitment (over 18months) completed (last

patient in)

7 2 31/10/2013 No 31/10/2013

57 Data collectionperformed, i.e. last

patient out

7 2 31/10/2013 No 31/10/2013

58 Data lock, data baseclean

7 2 30/11/2013 No 30/11/2013

59 Evaluation andstatistical analyses

completed

7 2 28/02/2014 No 28/02/2014


8 4 30/11/2011 No 31/03/2013 Contracts have beensigned between

coordinating center andall participating sites


8 4 31/12/2011 No 31/03/2013 Due to delay in receivingimportant elements forprotocol finalization

62 Approved protocol 8 4 31/01/2012 No 31/12/2012 Comprehensive draftdone by month 15, could

not be finalized due tomissing elements from

earlier WPs


Boards) received

8 4 30/04/2012 No 31/03/2013 Due to delay in receivingimportant elements forprotocol finalization

64 Kick off and training 8 4 30/04/2012 Yes 04/05/2012 Training Meeting


Page - 14 of 24

Meetings performed performed

65 CRF done, ready for use 8 4 30/04/2012 No 31/03/2013 Delayed due to delay ofprotocol (MS62)

66 Start recruitment (firstpatient in)

8 4 31/05/2012 No 30/06/2013 Will be somewhatdelayed, depending on

delay in protocoldevelopment, see above


patient in)

8 4 31/10/2013 No 31/10/2013


patient out

8 4 31/10/2013 No 31/10/2013


8 4 30/11/2013 No 30/11/2013


completed

8 4 28/02/2014 No 28/02/2014


9 1 30/11/2011 No 30/09/2012 Hospital JRO contractsstill pending


9 1 31/12/2011 No 30/09/2012 New documents need tobe prepared for secondsubstantial amendment

73 Approved protocol 9 1 31/01/2012 No 30/07/2012 Original protocol andfirst substantial

amendment approved,but second substantialamendment pending


Boards) received

9 1 30/04/2012 No 15/08/2012 See MS73

75 Kick off and trainingMeetings performed

9 1 30/04/2012 No 30/09/2012 Meetings have happened,but one to one training

with Healthtracker needsto be arranged.

76 CRF done, ready for use 9 1 30/04/2012 No 30/07/2012 Some revisions needed tocover latest protocol if

approved by ethics

77 Start recruitment (first 9 1 31/05/2012 No 31/05/2012


Page - 15 of 24

patient in)


patient in)

9 1 31/10/2013 No 31/10/2013


patient out

9 1 31/10/2013 No 31/10/2013


9 1 30/11/2013 No 30/11/2013


completed

9 1 28/02/2014 No 28/02/2014

82 Checking theassessment instruments

10 5 30/11/2011 Yes 31/01/2012

83 Contribution to thestudy website

10 5 31/01/2012 Yes 01/05/2012 Translation completed

84 Booklets of exercisesand written guidance

10 5 29/02/2012 No 31/12/2012 Partially existing (seeassessment instruments)

85 Kick-off meeting: introon assessment

procedures and schedule

10 5 30/04/2012 Yes 30/04/2012

86 Rater trainings toascertain rating

standards

10 5 30/04/2012 Yes 04/05/2012 training workshop,furhter training willfollow in accordancewith the coordinator

87 Checking the GCPcertificates of the

research staff (annually)

10 5 31/10/2012 No 31/10/2012

88 Checking the GCPcertificates of the

research staff (annually)

10 5 31/10/2013 No 31/10/2013

89 Discussion of studydesign and procedures

11 11 31/10/2011 Yes 06/12/2011 Completed afterdiscussion at Munich

General Assembly (Dec2011)

90 Preparation of aroadmap for the work of

the IAAG




Page - 16 of 24

91 Guidelines for managingpatent’s data privacyand confidentiality



92 Applications for the IRBfor each study site

11 11 31/05/2011 Yes 31/12/2011 For validation studyonly. In process for

clinical studies


Boards) received

11 11 30/04/2012 Yes 31/03/2012 For validation studyonly. To be achieved for

clinical studies

94 Approval ofdissemination plan

12 8 30/11/2010 Yes 11/12/2010

95 Project and studywebsite online

12 8 30/01/2011 Yes 21/05/2011

96 Announcement of studylaunch, Summary

objectives and methods

12 8 30/11/2011 Yes 01/11/2011 Preliminary informationto scientific

organizations and patientorganisations (feb/may2012). Another contact

planned after ethicsapproval.

97 All relevant researchersreceived information

packages

12 8 31/12/2011 Yes 06/12/2011 Booklets for patients,parents and professionals

in English and French(other translations to be

finalized).

98 Educational packagesfor investigators and

staff

12 8 31/01/2012 No 15/07/2012 Educational packagesonline after trainingsession may 2012.

99 Educational packagesfor families and general

public

12 8 31/01/2012 No 15/07/2012 Educational packagesonline after trainingsession may 2012

100 First contact withpatient organizations,

professionals networks

12 8 31/01/2012 Yes 03/02/2012 Patient organizationrepresentative contacted

3/02/2012 forpreliminary informationabout STOP and STOP

website

101 Trimestrial newsletterson study implementation

and progress

12 8 31/07/2012 No 01/10/2012 STOP studies not started


Page - 17 of 24

102 Workshops forprofessionals (STOP

study and related topics)

12 8 31/10/2012 Yes 06/03/2012 EPA march 2012:scientific symposium

103 Update of studyprogress to heads of

(inter-)national societies

12 8 31/10/2012 Yes 31/05/2012 STOP studies not started.Preliminary informationscheduled for the 31 may

2012 (scientificcommittee of the

SFPEADA)

104 Scientificcommunication plan

(methods, results)

12 8 31/10/2012 No 31/12/2012 STOP studies not started


Page - 18 of 24

4. Explanation of the use of the resourcesDuring the transitional period the use of resources can be edited both in SESAM and in FORCE by those who started to edit their scientific reports before it becameavailable in FORCE.<br>In c ase of inconsistencies, please contact the coordinator.

UNIVERSITY COLLEGE LONDON

Work Package Item description Amount Explanations

WP2, WP9 Personnel direct costs 21042.25 Noha IESSA 4,00 PM, Heather Hanna 1,95 PM & Bev Botting 1,00 PM

WP2, WP9 Travel 21285.28 Stop Kick-Off Meeting; STOP project meetings in Milan, Barcelona, Munich

WP2, WP9 Consumables 4307.30 Office Consumables, 2 Laptops Hard/software

WP9 Other direct costs 5233.66 Database fee; job advert

Indirect costs 31121.09 60% Flat rate

Total: 82989.58

STICHTING KATHOLIEKE UNIVERSITEIT


WP7 Personnel direct costs 8082.13 Cost Prof.dr. J.K. Buitelaar

WP7 Other direct costs 1253.20 Travel costs (Glennon) - WP leader meeting - Munich 2011, Travel costs (Glennon) - STOP meeting -Windsor 2010

Indirect costs 5601.20 Flat rate 60%

Total: 14936.53

ACADEMISCH ZIEKENHUIS GRONINGEN


WP7 Personnel direct costs 4112.42 PM of the psychiatrist

WP7 Travel costs 1269.98 Kick-off meeting London december 2010


Total: 8611.84


Page - 19 of 24

ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT


WP8 Personnel direct costs 6267.91 Salary of project leader 0,48 PM

WP8 Consumables 156.50 Banking fee for receipt of payment.

WP8 Travel 2159.38 Travel to project meetings in London + Barcelona


Total: 13734.06

UNIVERSITAET ULM


WP10 Travel Costs 944.62 Project Meetings in Barcelona and Munich


Total: 1511.39

UNIVERSITY OF DUNDEE


Total cost 0.00 No costs yet

Total:

THE SCHOOL OF PHARMACY, UNIVERSITY OF LONDON


WP2, 9 Personnel direct costs 21779.88 Ms Noha IESSA

WP2, 9 Remaining direct costs 1013.59 STOP Meetings and Consumables


Total: 36469.55


Page - 20 of 24

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS


WP1,4,5,7,9,12 Personnel direct costs 6587.71 Salary of professor Diane Purper-Ouakil (investigator) for 10 months, and salary of CRA Claire Baillon for 2months.

WP12 Other direct costs 3365.42 Travel and subsistence fees for meetings in Europe (London December 2010, Barcelona May 2011, MunichOctober/November/December 2011)


Total: 15925.01

CONSORCIO CIBER PARA EL AREA TEMATICA DE SALUD MENTAL


WP4, 5 Personnel direct costs 17494.00 Pre-doctoral Researcher (9 PM) develop a tool and methodology for assessing psychosocial risk factors inchildren and adolescents with a suicide attempt

WP4 Subcontracting 785.00 Subcontracting of translator to translate STOP documents and scales

WP11 Other costs 4080.37 Travel costs to attend several STOP meetings

Indirect costs 4314.87 Standart-flat rate of 20% of DC (except subcontracting)

Total: 26674.24

FUNDACIO PRIVADA CLINIC PER A LA RECERCA BIOMEDICA


WP5 Personnel direct costs 47719.94 Cost pertaining to a part time project manager and some hours of the researcher team for 4 member more

WP5 Travel 6606.55 4 consortium meeting ( London, Barcelona, Prague, Munich)


Total: 86922.38

UNIVERSITA DEGLI STUDI DI CAGLIARI



Page - 21 of 24

WP4,5,7,8,11,12 Personnel direct costs 27540.54 2 full professors, 1 researcher, 2 assistant researchers and 2 administratives for 5,90 person/month

WP4,5,7,8,11,12 Travel and subsistence 3139.40 Scientific Kick-off meeting, Scientific meeting, Steering commitee meeting

WP4,5,7,8,11,12 Equipment 948.34 Personal computer (depreciation for 18 months)

WP4,5,7,8,11,12 Other costs 124.51 Bank expenses


Total: 50804.46

True Clarity Limited


WP6 Personnel direct costs 41975.70 Running costs of full Scrum team consiting of business analyst, project manager, 3-4 developers and 1-2testers.

WP6 Travel and subsistence 1657.20 STOP Meetings

Indirect costs 26179.74 Based on 60% special transition flat rate

Total: 69812.64

KING'S COLLEGE LONDON


WP3 Personnel direct costs 41485.22 Dr Aitchison (1.11PM); Prof Craig (0.44PM); Dr Paya-Cano (2.66PM); Dr Curran (1.59PM)

WP3 Consumables 13850.00 Consumables: Lab consumables, shipment costs

WP3 Travelling 768.84 Travelling: Aitchison - travel to Barcelona for conference May-12 including flights and accomodation; Curran- travel to Barcelona for conference May-12 including flights and accomodation


Total: 89766.50

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)


total costs 0.00 No costs yet


Page - 22 of 24

Total:

Concentris Research Management GmbH


WP1, 12 Personnel direct costs 102038.42 Staff costs

WP12 Subcontracting 10076.00 Subcontract for website design and development

WP1, 12 Other costs 9952.40 Consumables, Travelling, Equipment


Total: 144464.98

Great Ormond Street Hospital for Children NHS Trust


WP6 Total cost 0.00 Terminated

Total:


Page - 23 of 24

Attachments Core of the Report for the Period.pdf

Grant Agreement number: 261411

Project acronym: STOP

Project title: Suicidality: Treatment Occurring in Paediatrics

Funding Scheme: CP

Project starting date: 01/11/2010

Project end date:

Name of the scientific representative of theproject's coordinator and organisation:

Dr. Paramala Santosh UNIVERSITY COLLEGELONDON

Period covered - start date: 01/11/2010

Period covered - end date: 30/04/2012

Name

Date

This declaration was visaed electronically by Paramala SANTOSH (ECAS user name nsantopl) on


Page - 24 of 24